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There is another world besides ours, another realm we will soon

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

discover and the future is ours if we dare to take it. If we w

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ll take it and seize the day or we can sit idle, while opportun

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ty evades us and we continue on the path of our self-defeating

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ays repeating our history as mankind seems to be doomed to do.

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ou see the truth is that; The New World and Future is Ours if w

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

Dare!

What new World you say? Well what about Space and the f

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ture of Space Colonies? What about Utopia here on Earth? What a

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

out the virtual reality world available soon at a theatre near

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ou? What about a World of Peace? What about free energy, though

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

swapping or even living forever? You know all of this is possi

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

le and the future is coming. Shall we embrace it or fight it?

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

he New World and Future is Ours if we Dare! There are multiple

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

imensions and other worlds to be discovered and enjoyed. As a f

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

turist many people ask me why I am such an optimist? Well in re

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

lity I am not the epitome of optimism, I am merely suggesting w

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

take a look at some of these possible futures and have some di

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

logue and ask ourselves do we dare to embrace the future or wil

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

we succumb to the sound and fury of millenniums gone by and do

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

m ourselves to repeat over and over again. That is the question

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Advice Pool - The New World and Future is Ours if we Dare!

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